Cleared Traditional

K915508 - DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)

K915508 is the FDA 510(k) clearance for DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K915508 · Diagnostic Systems Laboratories, Inc. · Immunology device
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Mar 1992
Decision
99d
Days
Class 2
Risk

K915508 is an FDA 510(k) clearance for the DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500). Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on March 17, 1992 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K915508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date March 17, 1992
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 104d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - JZG System, Test, Beta-2-microglobulin Immunological

All 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K915508.
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · Coulter Corp. · Sep 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132 · Elias U.S.A., Inc. · May 1992
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131 · The Binding Site, Ltd. · Nov 1991
DSL BETA 2 MICROGLOBULIN (DSL 6200)
K911881 · Diagnostic Systems Laboratories, Inc. · Sep 1991